Please carefully read the following information regarding consent, and indicate
below whether you agree to participate in this program.
University at Buffalo
Consent to Participate in a Research Study
|Title of Protocol:
||Multiple Sclerosis and Vocational Accommodations
||Ralph H B Benedict, PhD
|Site of Investigation:
||The Jacobs Neurological Institute; The Buffalo General Hospital
You are being asked to participate in a research study. The purpose of this document is to provide you with information to consider in deciding whether to participate in this research study. Your consent should be made based on your understanding of the nature and risks of the treatment, device, or procedure. Please ask questions if there is anything you do not understand. Your participation is voluntary and will have no effect on the quality of your medical care if you choose not to participate.
PURPOSE OF THE RESEARCH STUDY
Multiple sclerosis (MS) is a disease that can cause/result in a variety of potentially disabling symptoms such as walking impairment, cognitive impairment, difficulty regulating body temperature, and severe fatigue. The debilitating effects on work that some of these disabling symptoms cause can potentially be improved by modifying an employee's work environment or job characteristics. The purpose of this study, which involves research, is to identify job modifications that may prolong employment.
You are being asked to participate because you are 18 - 70 years of age, have a clinical diagnosis of Multiple Sclerosis (MS), or are matched on demographic variables to an MS sample and you are employed in some capacity. Or, you have previously participated in this research study and have become unemployed/disabled (since you first completed this survey).
Once you are screened and deemed eligible (either in person or over the phone), you may be scheduled to come in to the Conventus center for neuropsychological testing and later asked to complete an online survey.
The neuropsychological testing battery will assess your memory, visual acuity and thinking speed, and will take approximately 60 to 90 minutes to complete. You may be asked to complete the online vocational study
12 times, every three months—at months 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36. The survey will take approximately 15 minutes to complete. The research study for each subject will last for 3 years, regardless of whether you are a MS patient or Healthy Control. The survey will include questions about your current job status, job accommodations you receive, and a questionnaire about your thinking, learning and memory. You may also be asked for your feedback on the questions and information in the survey through a focus group or email, this is an entirely optional component of the study and if you choose not to provide feedback you can still participate in the rest of the study.
RISKS / DISCOMFORTS
There are no foreseeable risks, side effects, or discomfort from taking part in this research study.
There is no direct benefit from participating in this study; however, your participation will provide information that may benefit others with MS.
ALTERNATIVES TO PARTICIPATION IN THE RESEARCH STUDY
Participants may decline to participate.
You will be told of any new findings developed during the course of the study that may relate to your willingness to continue your participation.
COST ASSOCIATED WITH THE RESEARCH STUDY
You will not be required to pay for any study procedures.
COMPENSATION FOR SUBJECT PARTICIPATION
There is no compensation associated with this study.
Information related to you will be treated in strict confidence to the extent provided by law. Your identity will be coded and will not be associated with any published results. Your code number and identity will be kept in a password protected file on a private computer of the Principal Investigator, your online responses will be kept on a secure computer hosted by www.vovici.com and the internet communication coded using Secure Socket Layer (SSL) encryption. In order to monitor this research study, representatives from the Health Sciences Institutional Review Board may inspect the research records, which may reveal your identity.
Your participation in this study is voluntary (a choice made by you). You may refuse to participate or may discontinue participation at any time during the study without penalty or loss of benefits to which you are otherwise entitled. If you choose to withdraw from the study, no further information will be collected from you or about you. You should know, however, that the information collected about you up to the time of your withdrawal may continue to be used.
Dr. Ralph Benedict, Principal Investigator, is conducting this research study. This study has no outside sponsorship.
All of the above has been explained to me and all of my current questions have been answered. I am encouraged to ask questions about any aspects of this research study before signing this document. If, in the future, I have questions, concerns, or complaints about the research, I should contact:
Name: Dr. Ralph Benedict
Title: Principal Investigator
Phone Number: (716) 323-0556
If I have any questions, concerns, or complaints about my rights as a research participant or want to speak to someone who is not associated with the research, I should contact the staff at the Office of the Health Sciences Institutional Review Board, University at Buffalo: (716) 888-4888.